The purpose of this study is to examine how Buprenorphine, a form of opioid addiction treatment, changes the ability to think and reason among people addicted to opiates, who are either HIV negative or HIV positive. In addition, blood samples will be stored for HIV+ and HIV- individuals who take buprenorphine to study its effect. We hypothesize that the HIV positive participants will demonstrate significant improvement in thinking and reasoning ability at 3 and 6 months compared to baseline, but that their thinking and reasoning ability will still be lower than HIV negative participants. We also hypothesize that the biomarkers in participants' blood samples will be associated with measures of change in thinking and reasoning ability.

Opioid-dependent drug users who are initiating buprenorphine treatment at the Albert Einstein College of Medicine Division of Substance Abuse (DoSA) or at Montefiore's Comprehensive Health Care Center (CHCC).

Eligibility

Ages Eligible for Study:

18 Years to 60 Years (Adult)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

Yes

Sampling Method:

Non-Probability Sample

Study Population

Subjects for this study will be drug users with a diagnosis of opioid dependence who are initiating buprenorphine therapy at a DoSA clinic or at the CHCC. The study population is expected to reflect the ethnic composition of the opioid-dependent population in the Bronx. This population is composed of 40% women, and is 24% African-American, 58% Hispanic and 17% Caucasian. Both males and females with opioid dependence who are initiating buprenorphine will be recruited for the proposed study, and, based on our previous studies, we expect to recruit high proportions of women and minorities.

Criteria

Inclusion Criteria:

Documented HIV-serostatus

English-speaking

Age 18-60

Able to give voluntary, signed informed consent

Plan to initiate buprenorphine treatment in the next month.

Exclusion Criteria:

Over age 60: Participants over the age of 60 will be excluded, as normal age-associated cognitive changes may confound neuropsychological (NP) assessment and diagnosis of HIV-related cognitive disorders.

Acute intoxication due to alcohol or other drugs, as assessed by research staff.

Use of buprenorphine in the past month, either prescribed or purchased on the street.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01108679

Locations

United States, New York

Fordham University

Bronx, New York, United States, 10458

Albert Einstein College of Medicine

Bronx, New York, United States, 10467

Sponsors and Collaborators

Albert Einstein College of Medicine of Yeshiva University

Montefiore Medical Center

Fordham University

Investigators

Principal Investigator:

Julia Arnsten, M.D., M.P.H.

Albert Einstein College of Medicine of Yeshiva University

More Information

Responsible Party:

Dr. Julia Arnsten, Albert Einstein College of Medicine of Yeshiva University